SMITH & NEPHEW, INC. GII HOUSING REAMER DOME; PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY
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Catalog Number 71440142 |
Device Problem
Dull, Blunt (2407)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/08/2020 |
Event Type
malfunction
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Event Description
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It was reported that the reamers were found dull, during surgery.There was no delay in the case.The case was finished with the same device.
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Manufacturer Narrative
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The device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.
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